Eligibility
as Principal Investigator on proposals. The UVA policy
Grants and Contracts - Definition, Solicitation, Clearance, and
Acceptance states that proposals may only be submitted by elected
members of the faculty: Professors, Associate and Assistant Professors,
Instructors and Lecturers. Other individuals may serve as PIs, if
allowed by the funding program and approved by the Office of Grants and
Contracts.

Grants provide
assistance to the investigator with relatively few restrictions. The PI
is responsible for deciding the direction of the research program on a
day-to-basis, within the general scope approved by the sponsor. The
sponsor believes that the proposed work scope can be accomplished.
Federal grant opportunities are announced by program announcements or
more focused Requests for Applications (RFAs). Purchased equipment
generally vests with the grantee. Intellectual
property developed during the course of the research is owned by
the grantee institution, and may be developed and licensed by it to
other entities.

Cooperative
agreements are similar to grants, and are announced via RFAs.
The sponsor's technical contact is substantially involved in assisting
or managing the agreement. Sponsor and awardee responsibilities are
spelled out in the notice of award. The terms of the award determine
ownership of purchased equipment, intellectual property rights, and the
(generally greater) reporting requirements.

Contracts are
agreements with clearly defined work scopes, the results of which
("deliverables") are generated for the direct benefit or use of the
sponsor. By accepting a contract, the awardee is agreeing to provide
those deliverables. Contract scopes of work are established by the
sponsor. The contract specifies applicable regulations, reporting
requirements, approvals that must be obtained prior to initiating work,
review of manuscripts prior to submission for publication, title to
equipment, and so on. Reporting requirements for contracts generally
are more substantial than for cooperative agreements or grants.
Reimbursement is effected by invoicing the sponsor.

Clinical trials agreements are contracts for the study, in human
subjects, of devices, therapies, or preventatives for a particular
disease or medical condition. Clinical trials may be investigator- or,
more commonly, sponsor-initiated. The latter are required for the
licensure of a product for sale to the public. The scope of work and
study procedures are defined in the study protocol, which must be
approved by the UVA IRB
for Health Sciences Research prior to the onset of recruitment.
Multi-site studies may be managed by a clinical research organization
(CRO) under contract from the sponsor. Reimbursements in clinical
trials agreements often are driven by the number of patients enrolled,
specific study visits/procedures/evaluations, and data forms completed.
Multi-site study data are controlled by the sponsor, though the
University retains the right to publish reports based on subjects
enrolled at its own site. Intellectual property generated within the
scope of the protocol generally is owned by the company; title to other
IP belongs to the University, generally with the sponsor receiving an
option to negotiate an exclusive license.

Industry-academia
collaborations. There are many ways to collaborate with
industry. Each carries responsibilities that differ from the
traditional relationship between academic institutions and foundations,
professional associations, or government agencies. Unless otherwise
indicated, the SOM contact for these agreements and collaborations is
the Office of Grants and
Contracts. The most common agreements with industry are:

Sponsored Research. Investigator-initiated research projects
supported by industry. The Office of Grants and Contracts will
negotiate a research agreement covering ownership and licensing of
intellectual property (IP), publication rights, confidentiality, and
ownership of data.

Collaboration Agreement. Projects in which University and company
both contribute to the development and performance of the scope of
work.

Subcontract. Company asks PI to perform a specified subproject
embedded within a larger project. If the subcontract will be awarded by
a company in which the faculty member has ownership or other financial
interest (e.g., SBIR or STTR), a conflict-of-interest waiver or
management plan must be obtained to comply with the Virginia conflict
of interest statute.

Clinical Trial. Industry-generated protocol to evaluate safety,
pharmacokinetics, or efficacy of a company product. The
Clinical Trials Office can help with budget development and
post-award monitoring.

Materials Transfer Agreement (MTA). The company provides materials
required for your research, or vice versa. If outgoing UVA materials
are covered by an invention disclosure, the UVA Licensing and Ventures
Group will participate in the negotiation process. Ownership of
derivatives and modifications of the original material may slow
negotiations; this is less problematic if the agreement does not allow
the recipient to create derivatives or modifications of the original
material.

Consulting Agreement. PI provides professional expertise to the
company. All consulting agreements must be approved by one's chair and
the Office of Grants and Contracts, per
SOM consulting policy. Proposed consulting agreements may be routed
through the University (allowing the use of UVA facilities) or as a
direct agreement between faculty and company (proscribing the use of
UVA resources, staff, space, etc.) Faculty should exercise care that
their level of consulting activities remains consistent with
out-of-office allowances under UVA
policy and that remuneration rates reflect fair market value.

Licensing Agreement. Company licenses the use of UVA intellectual
property, often for further commercial development. Contact the UVA
Licensing and Ventures Group if you receive such a request.
Inventors should help identify potential licensees for the invention;
once a licensee has been identified, inventors should work only with
the Patent Foundation.

Gift. Industry provides funds or equipment for use in faculty
research. Gifts may not be associated with deliverables such as reports
or data, use of human subjects or animals, or assignment of rights to
intellectual property
per UVA policy. When in doubt, contact the Office of Grants and
Contracts. Gifts generally are donated to the Health
System Development Office.

Whom to notify, and when,
during proposal development. The following proposals require
that you notify one or more administrative offices prior to
submission:

Funding programs allowing a restricted number of proposals per
institution. Contact Dr. Steven
Wasserman, Assistant Dean for Research. The Office for
Research or the Office of
the VP for Research conduct internal competitions when the number
of potential applicants exceeds the allowable number of nominees.
Pre-proposals will be requested approximately two months prior to the
agency deadline.

Proposals requiring increases in numbers of research animals.
Discuss your potential animal needs with Dr. Sanford Feldman, Director,
Center for Comparative Medicine and then obtain written approval from
the Dean's Office.

Proposals requiring institutional support or a letter from the
Dean. Contact the Office for Research with sufficient
time to review your request for support and to generate a support
letter.

Help with proposal
development

With your research mentor, develop a strategy for obtaining
funding, a timeline for seeking funds, and the structure of your
proposals. Arrange an in-house pre-review of your proposal prior its
submission.

Your department/center research administrator can help develop
required forms, the budget, and budget justification. The Office for
Research has developed "boilerplate" descriptions of resources
such as core facilities and computer network capabilities. Also see
"Materials for the development of grant proposals" on that page.

NIH
RePORTER allows you to search current or previously-funded NIH
projects. You can filter a search by key words, general topics,
sponsoring Institutes/Centers, year of award, etc. Consider how your
proposal would build on prior or current NIH projects and how your work
will be relevant to public health. The site also can be used to locate
potential collaborators.

Attend the SOM grant and research support workshop, conducted by
the Office for Research and Office of Grants and Contracts, under the
auspices of SOM Faculty Development. This workshop is designed to help
participants prepare effective grant proposals, and includes strategies
for writing applications, identifying available NIH and foundation
grants, grant submission procedures, and human subjects and animal use
requirements.

Timeline for proposal
development. The following schedule was adapted from SK Inouye
& DA Fiellin 2005 Ann. Intern. Med. 142:274-282). Their
timeline is appropriate for programs with predictable annual cycles.
More experienced investigators can work on a shorter timeline.

1 year before submission. Conceptualize the project. Begin
generating preliminary data. It may help to start developing your
specific aims. Discuss the broad outlines of your proposal with the
agency's program officer, your mentor, and colleagues. The program
officer may offer advice on how to shape your proposal to increase its
chance of being funded or refer you to other programs that better fit
its direction and scope.

10 to 12 months before submission. Obtain and review
program guidelines and forms.

10 to 11 months before submission. Review recent awards
from the funding agency and determine potential reviewers. Abstracts of
NIH awards can be obtained using the NIH RePORTER
system.

3 months before submission. Develop budget/justification.
If your scope of work changes later, revisit both to ensure appropriate
funding before routing it to the Office of Grants and
Contracts. The SOM
Clinical Trials Office must review clinical studies budgets to
ensure proper billing to study vs. insurance providers.

2 months before submission. Have your working draft and
abstract reviewed by your mentor, collaborators, and colleagues. Some
departments or centers require that the PI participate in a structured
review session before submission. Continue to revise the proposal.

Two weeks before submission. Begin the internal approval
process.

Other. Inform your research administrator of your
intention to submit the proposal (including agency, program, and
deadline), as early as possible. He or she may recommend different
administrative timelines than the above.

Hints for
successfully negotiating the UVA approval process

Notify your department administrator of your intent to submit a
proposal and its deadline as soon as possible; coordinate your
responsibilities for each section of the proposal.

Include full F&A costs in your budget or document sponsor
restrictions on F&A when routing the proposal to the Office of
Grants and Contracts.

Make sure that all signatures, including your collaborators' chairs
and subcontracting institutions, have been obtained.

Allow sufficient time for department and Grants and Contracts
review before the funding deadline.

The NIH
application cover letter. NIH proposals generally are
submitted to the Center for
Scientific Review (CSR), which conducts the review process. CSR
staff decide which Institute or Institutes are most appropriate to
administer your project, if awarded. They also determine the study
section best suited to review your proposal. By default, these
decisions are made on the basis of your title and abstract. You can
influence these decisions by including with your proposal a cover
letter describing which Institute(s) and study section(s) you feel are
most appropriate. Remember to justify such a request. Names
and areas of scientific interest for study sections can be found on
the CSR web site. Your cover letter also can list individuals who
should not review your proposal due to conflicts of interest. Finally,
cover letters can be used to justify late submission of a proposal
(e.g., due to inclement weather or participation on an NIH study
section).

Sharing of biomedical research resources. The NIH Office of
Technology Transfer provides information on this policy, which
addresses "terms for disseminating and acquiring unique research
resources developed with federal funds and is intended to assist
recipients in complying with their obligations under the Bayh-Dole Act
and NIH funding policy."

The proposal approval process
at UVA. All grant and contract proposals must be approved by
the University before submission to the sponsor. At the SOM, proposals
must be endorsed by the Principal Investigator, Chair, and the Office
of Grants and Contracts.

The fiscal/administrative description of the proposal and approval
signatures are collected on a proposal approval sheet (also known as
"the goldenrod," after its former color). Grants and Contracts has
posted a version for NIH e-SNAP
proposals and a generic SOM
version. Your research administrator should help you complete this
form, though you, as Principal Investigator, are responsible for
reviewing and approving its contents. Forward the approval sheet,
technical proposal, budget, justification, and other supporting
documents to your Chair and then to Grants and Contracts (who require
at least seven working days before the submission deadline).
Grants and Contracts may ask additional questions concerning the
project or information on the approval form before it is signed and
ready for submission to the funding agency. Grants and Contracts
performs all electronic submissions of proposals to grants.gov (see notes
and reminders for submissions to grants.gov).

If your NIH proposal is likely to be funded, you will be asked to
submit just-in-time documentation of other grant support, IRB or IACUC
approvals, etc. You can send these directly to NIH, or via Grants and
Contracts.

Sponsors generally notify both the PI and either Grants and
Contracts or Sponsored Programs. Sponsored Programs then creates an
internal account in the Oracle system, which may take a few weeks to
complete. To avoid delays in initiating your project, ask your
department administrator to request an at-risk
Oracle account as soon as it is likely that your project will be
funded. This will allow you to encumber and spend funds in a timely
manner.